PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
Fentanyl (transmucosal)
PSUR-outcome
|
21/04/2021
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Primidone
PSUR-outcome
|
21/04/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lidocaine/Phenylephrine/Tropicamide
PSUR-outcome
|
21/04/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clotiazepam
PSUR-outcome
|
21/04/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bortezomib
PSUR-outcome
|
21/04/2021
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Piroxicam
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clarithromycin
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tramadol
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Irinotecan
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Xylometazoline
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website